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Completed Phase 3 Interventional Accepts healthy volunteers

Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage

ClinicalTrials.gov ID: NCT00009620

Public ClinicalTrials.gov record NCT00009620. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 7:10 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized Clinical Trial of Antenatal Phenobarbital in the Prevention of Neonatal Intracranial Hemorrhage

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This large randomized trial tested whether phenobarbital given to a pregnant woman about to deliver a premature infant would prevent brain injuries in their newborns. Women with 24 to 32 week fetuses who were in preterm labor and were expected to deliver within 24 hrs were randomized to phenobarbital or usual care. They were treated until they deliver or the fetus reaches 33 wks gestation. Babies were followed until discharge and evaluated at 18-22 mos corrected age for neurodevelopmental outcome.

Study identification

NCT ID
NCT00009620
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
610 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 1993
Primary completion
Jan 31, 1995
Completion
Jan 31, 1997
Last update posted
Mar 21, 2019

1993 – 1997

United States locations

U.S. sites
11
U.S. states
10
U.S. cities
11
Facility City State ZIP Site status
Stanford University Palo Alto California 94304
Yale University New Haven Connecticut 06504
George Washington University Washington D.C. District of Columbia 20052
Emory University Atlanta Georgia 30303
Indiana University Indianapolis Indiana 46202
Wayne State University Detroit Michigan 48201
University of New Mexico Albuquerque New Mexico 87131
Cincinnati Children's Medical Center Cincinnati Ohio 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital Cleveland Ohio 44106
Brown University, Women & Infants Hospital of Rhode Island Providence Rhode Island 02905
University of Tennessee Memphis Tennessee 38163

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00009620, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 21, 2019 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00009620 live on ClinicalTrials.gov.

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